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Papers of the Week


Papers: 6 Mar 2021 - 12 Mar 2021


Human Studies


2021 Mar 04


J Pain

Spa therapy for the treatment of fibromyalgia: an open, randomized multicenter trial.

Authors

Maindet C, Maire A, Vermorel C, Cracowski C, Rolland C, Forestier R, Comte A, Roques C-F, Serra E, Bosson J L
J Pain. 2021 Mar 04.
PMID: 33677113.

Abstract

Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference (MCID) at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire (FIQ) score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a MCID (p=0.013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia. PERSPECTIVE: A 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate vs. delayed (i.e. after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02265029.